NCT06259162

Brief Summary

This study is the experimental study for relationship between LAG-3 expression / immue checkpoint protein expression and neoadjuvant chemotherapy plus immune checkpoint inhibitor in triple negative breast cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Nov 2022Dec 2027

Study Start

First participant enrolled

November 18, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

2.6 years

First QC Date

February 6, 2024

Last Update Submit

February 6, 2024

Conditions

Triple Negative Breast CancerImmune Checkpoint Inhibitor

Outcome Measures

Primary Outcomes (1)

  • LAG-3 expression/immune checkpoint preotein expression

    Relationship neoadjuvant chemotherapy plus immune checkpoint inhibitor

    Before chemotherapy, 1 weeks & 3 weeks after chemotherapy, curative surgery

Study Arms (1)

LAG-3 expression/immune checkpoint protein expression evaluation

EXPERIMENTAL
Procedure: LAG-3 expression / immune checkpoint protein expression

Interventions

LAG-3 expression / immune checkpoint protein expressionPROCEDURE

Evaluate the tissue and blood before and after chemotherapy

LAG-3 expression/immune checkpoint protein expression evaluation

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Planned neoadjuvant chemotherapy
  • Triple negative breast cancer

You may not qualify if:

  • HER2-positive breast cancer
  • Hormone receptor positive breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ji-Yeon Kim

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Ji-Yeon Kim

CONTACT

82-2-3410-3459jyeon25@skku.edu

Mee Ryung Hong

CONTACT

82-2-2148-7147ring7629@naver.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 14, 2024

Study Start

November 18, 2022

Primary Completion

July 1, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)